MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H170

Device Problem Microbial Contamination of Device (2303)

Patient Problems Fever (1858); Chills (2191)

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

E1 ¿ postal code (b)(6).It was reported that the scopes are not expected to be returned to olympus for evaluation and analysis.The customer provided the cleaning, disinfection and sterilization (cds) processes performed onsite at the user facility.According to the customer, all precleaning and disinfection was performed step by step and was done correctly.The device underwent eto sterilization.The scopes were last reprocessed the day before the exam.Precleaning was performed immediately at the end of the exam.Water was aspirated through the instrument/suction channel with a suction pump.There were no abnormalities with the reprocessing accessories.Manual cleaning was performed after precleaning.The leak test was performed on the automated processing machine and detergent enzymatic indazyme 6 st renylab was used.Any area of the scope that can be brushed is brushed and those areas that it is not possible to brush are injected with enzyme solution, water, and are then dried.The user facility underwent a reprocessing in-service a couple of months ago which had been conducted by olympus.There have been no changes in the facilities reprocessing personnel since the last reprocessing in-service.It was reported that one of the technicians did not continue with the training.The scopes are stored in their own air-conditioned cabinet, in an upright position with the connectors facing up.Its unknown if all the channels were connected to tubes when connected to the automated processing machine.The field service engineer (fse) verified that in the clinic, there was no contact with the enzymatic, the cleaning valve was not used; this in the equipment's in which they already had.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Event Description

The olympus representative reported on behalf of the customer that an unknown amount of patients exhibited with fever and chills after undergoing an endoscopy exam.Although no patient infections were reported or confirmed, scopes had tested positive for unspecified microbial contamination.It is unknown if the scopes were used for a procedure after testing positive.This medical device report (mdr) is being submitted to capture the reportable malfunction of microbial contamination on the device.Related patient identifiers this event requires six (6) medwatches to reflect the unknown number of patients associated with the microbial contamination of the device (three patients per affected scope).(b)(6), gif-h170 (gastrointestinal videoscope) serial number (b)(6), ¿ patient one; (b)(6), gif-h170 (gastrointestinal videoscope) serial number (b)(6), ¿ patient two; (b)(6), gif-h170 (gastrointestinal videoscope) serial number (b)(6), ¿ patient three; (b)(6), gif-q180 (evis exera ii gastrointestinal videoscope) serial number (b)(6), ¿ patient one; (b)(6), gif-q180 (evis exera ii gastrointestinal videoscope) serial number (b)(6),¿ patient two; (b)(6), gif-q180 (evis exera ii gastrointestinal videoscope) serial number (b)(6), ¿ patient three.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17513098
• MDR Text Key: 321627670
• Report Number: 9610595-2023-11564
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170334115
• UDI-Public: 04953170334115
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1